药品注册申请号:009330
申请类型:NDA (新药申请)
申请人:COVIS
申请人全名:COVIS PHARMA GMBH
产品信息
产品号商品名活性成分剂型/给药途径规格/剂量参比药物(RLD)生物等效参考标准(RS)治疗等效代码该申请号批准日期该产品号批准日期市场状态
002 LANOXIN DIGOXIN INJECTABLE;INJECTION 0.25MG/ML Yes Yes AP 1954/11/16 Approved Prior to Jan 1, 1982 Prescription
004 LANOXIN PEDIATRIC DIGOXIN INJECTABLE;INJECTION 0.1MG/ML Yes Yes None Approved Prior to Jan 1, 1982 Prescription
批准日期,申请提交历史,通知信,药品说明书,审评文件等信息
提交状态日期提交号审批结论申请内容分类审评优先级;罕用药状态通知信、审评文件、说明书、包装标签备注
2024/06/20 SUPPL-39(补充) Approval Labeling STANDARD
2022/11/02 SUPPL-36(补充) Approval Labeling STANDARD
2018/09/20 SUPPL-33(补充) Approval Labeling STANDARD
2018/08/24 SUPPL-34(补充) Approval Labeling STANDARD
2016/12/01 SUPPL-31(补充) Approval Labeling STANDARD
2015/07/28 SUPPL-30(补充) Approval Labeling STANDARD
2013/05/16 SUPPL-27(补充) Approval Labeling UNKNOWN
2011/11/14 SUPPL-26(补充) Approval Labeling UNKNOWN
2010/02/05 SUPPL-25(补充) Approval Labeling UNKNOWN
2002/06/17 SUPPL-21(补充) Approval Manufacturing (CMC)
1998/07/15 SUPPL-20(补充) Approval Labeling STANDARD
1996/06/25 SUPPL-18(补充) Approval Labeling STANDARD
1995/08/30 SUPPL-17(补充) Approval Labeling STANDARD
1993/08/06 SUPPL-16(补充) Approval Manufacturing (CMC)
1992/05/07 SUPPL-15(补充) Approval Labeling
1991/09/06 SUPPL-14(补充) Approval Manufacturing (CMC)
1954/11/16 ORIG-1(原始申请) Approval Type 1 - New Molecular Entity PRIORITY
与本品相关的专利信息(来自FDA橙皮书Orange Book)
关联产品号专利号专利过期日是否物质专利是否产品专利专利用途代码撤销请求提交日期专利下载备注
与本品相关的市场独占权保护信息
关联产品号独占权代码失效日期备注
与本品治疗等效的药品
活性成分:DIGOXIN 剂型/给药途径:INJECTABLE;INJECTION 规格:0.25MG/ML 治疗等效代码:AP
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
009330 002 NDA LANOXIN DIGOXIN INJECTABLE;INJECTION 0.25MG/ML Prescription Yes Yes AP Approved Prior to Jan 1, 1982 COVIS
083391 001 ANDA DIGOXIN DIGOXIN INJECTABLE;INJECTION 0.25MG/ML Prescription No No AP Approved Prior to Jan 1, 1982 HIKMA
040481 001 ANDA DIGOXIN DIGOXIN INJECTABLE;INJECTION 0.25MG/ML Prescription No No AP 2003/08/21 SANDOZ
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药品NDC数据与药品包装、标签说明书
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